Journal of Clinical and Aesthetic Dermatology • Hot Topics in Melanoma July 2025 • EXPERT PERSPECTIVES

Dr. Rizzo discusses research¹ that he and his co-authors presented at the 2025 AAD Annual Meeting, which validated the performance of the 31-gene expression profile (GEP) test in a large, unselected cohort by demonstrating melanoma-specific survival stratification and survival benefit in 31-GEPtested patients in an updated analysis of almost 10,000 clinically tested patients included in SEER registry data.

“This study was a result of collaboration with the National Cancer Institute, using data from the Surveillance, Epidemiology, and End Results (SEER) database, including demographics and clinical and histopathological characteristics of tumors and their outcomes. The goal of the study was to validate the performance of DecisionDXMelanoma, which is a prognostic test based on 31-gene expression profiling (GEP). The test is performed on biopsy tissue; no additional tissue is needed. It’s an add-on test that provides additional risk stratification for our patients and additional information beyond the standard staging we use with the American Joint Committee on Cancer (AJCC).

These patients were tested prospectively, and this is the largest study of DecisionDX-Melanoma to date. It has previously been published in a similar analysis with three-year data and 4,687 patients, but this poster,¹ presented at the American Academy of Dermatology (AAD) Annual Meeting in March 2025 was an expanded analysis with five-year outcome data and more than double the number of patients. The two goals of the study were to validate that the 31-GEP test is able to predict and stratify the risk of melanoma-specific survival in a real-world, prospectively tested population, and to see if having the test made a difference on survival outcomes. If you look through the data on the poster, the answer is yes, and that was the answer in the three-year analysis. What we see when we look at all stages of melanoma, including 9,474 patients, is the 31-GEP test score is able to stratify and predict the risk of melanoma-specific survival, and it could do so completely agnostic to other standard staging criteria. It is a significant and independent predictor of melanoma-specific mortality. The 31-GEP test results are classified as low risk (Class 1A), intermediate risk (Class 1B/2A), or high risk (Class 2B), and both the intermediate- and high-risk scores are significant, independent predictors of melanoma-specific mortality in multivariable analyses. The other significant variables were Breslow thickness, age, mitotic rate, ulceration status, and nodal status, as would be expected. That’s the first part of the analysis; the test was validated and robust in a real-world prospectively tested cohort of almost 10,000 patients.

But the second part of the study is really interesting, which explored the question, “Did it make a difference?” We looked for patients in the SEER database who were tested with the 31-GEP test and compared them to patients matched in every other clinical, pathological, and socioeconomic variable, but who did not recieve a 31-GEP test. The idea is that the only difference between these two populations was the presence or absence of a 31-GEP test. The question was, “Was there a survival difference?” The answer was, just like in the three-year analysis, yes, there was a significant difference in survival; there was a 17-percent reduced mortality rate in those patients who had a 31-GEP test. It is reasonable to expect that having that 31-GEP test and knowing their personalized individual risk based on the genetic profile of their tumor guided management decisions to escalate the surveillance and management of these patients and allow for a better outcome. That really is what personalized medicine is. We want to treat individuals, not just the average, and we want to make sure it’s making a significant, meaningful difference. As a dermatologist who diagnoses and treats melanoma, I think this is super exciting, and as someone with a background in molecular genetics, I’m equally thrilled to see us being able to leverage molecular data into the way we care for our patients.

¹. Rizzo JM, Petkov VI, Kim YJ, et al. Realworld data demonstrate the 31-GEP stratifies risk of melanoma-specific mortality and is associated with improved survival: A SEER collaboration. Presented at: 2025 AAD Annual Meeting. March 6 to 11, 2025. Orlando, Florida. Available at: https://eposters.aad.org/abstracts/62266